01
Early clinical development
First-in-Human studies, early feasibility programs, and FDA EFS pathway design.
First-in-Human·Clinical·Post-market
From First-in-Human to Healthcare Value.
Value-based evidence generation for endovascular innovation.
CROEVS supports MedTech innovators across the full evidence lifecycle — First-in-Human studies, CE MDR and FDA pathways, post-market surveillance, health economics, and market access strategy.
Endovascular
MDR / FDA
Lifecycle Evidence
PMS / PMCF
Strategic Partners
Digital Platforms
— 02 / The methodology
Evidence across the full device lifecycle.
Nine interconnected stages from early innovation to demonstrated healthcare value. CROEVS designs the evidence pathway, executes it, and translates outcomes into market access.
— 03 / Value-based evidence
Beyond traditional CRO services.
Traditional evidence pathways generate clinical, regulatory, and economic data in sequence — each stream isolated from the next. CROEVS integrates them into one coordinated plan, where payer requirements shape clinical design and clinical outcomes anchor economic models, from day one.
Clinical outcomes+Economic outcomes+Real-world data=Healthcare value
— 04 / Services
Built for endovascular evidence.
Seven integrated service lines that operate across the device lifecycle — from early clinical development through value demonstration to market access.
02
Evidence generation
Pivotal trials, observational studies, and registry design and execution.
03
Regulatory strategy
CE MDR, IVDR, and FDA pathway design with end-to-end submission support.
04
PMS & PMCF
Post-market surveillance and clinical follow-up programs aligned to MDR.
05
HEOR & market access
Health economic models, payer dossiers, and reimbursement strategy design.
06
Digital platforms
Proprietary technology for evidence collection, monitoring, and operational scale.
07
Strategic consulting
Cross-functional strategy that spans the full evidence lifecycle — from clinical development planning and regulatory pathway design through health economics and market access.
— 05 / Specialization
Deep expertise in endovascular innovation.
Six clinical territories where CROEVS holds dedicated regulatory, clinical, and economic experience — strictly within the vascular and endovascular domain.
Endovascular surgery
EVAR, TEVAR, fenestrated and branched aortic repair.
Peripheral artery disease
Lower extremity intervention, critical limb ischemia, atherectomy.
Vascular disease
Venous disease, AV access, vascular malformations, DVT.
Interventional cardiology
PCI, complex coronary disease, calcified lesion management.
Neuro interventional
Stroke thrombectomy, aneurysm coiling, carotid stenting.
Vascular technologies
Stents, balloons, drug-eluting platforms, thrombectomy devices.
— 06 / Digital platform
Technology-enabled evidence generation.
Native PMCF apps for the life of the device.
Mobile applications built for clinical operators to capture patient history, intervention outcomes, and lifelong follow-up — structured for ongoing MDR dossier maintenance and continuous certification.
- Patient history & intervention outcomes
- Lifelong follow-up data capture
- MDR-aligned observational registries
- Built for clinical operator efficiency
9:41
←PMCF · 6-month follow-up
Patient
Case #2847
EVAR · left iliac branch · 2024-09
Outcome
Patency confirmed
Reintervention
Adverse event
Imaging
CTA · sac stable at 48 mm
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